AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
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| ClinicalTrials.gov Identifier: NCT01780987 |
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Recruitment Status
:
Completed
First Posted
: January 31, 2013
Results First Posted
: June 23, 2016
Last Update Posted
: June 23, 2016
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Sponsor:
Pfizer
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Deep Vein Thrombosis Pulmonary Embolism | Drug: Apixaban Drug: Unfractionated Heparin (UFH) Drug: Warfarin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Apixaban
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Experimental: Apixaban |
Drug: Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
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| Active Comparator: UFH/Warfarin |
Drug: Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Drug: Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5
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Primary Outcome Measures
:
- Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period [ Time Frame: Baseline to Week 24 ]Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Secondary Outcome Measures
:
- Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period [ Time Frame: Baseline to Week 24 ]VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late.
- Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) [ Time Frame: Baseline to Week 24 ]Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.
- Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) [ Time Frame: Baseline to Week 24 ]Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.
- Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period [ Time Frame: Baseline to Week 24 ]Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.
- Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods [ Time Frame: Baseline to Week 24 ]All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.
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| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute symptomatic proximal DVT with evidence of proximal thrombosis
- Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches
Exclusion Criteria:
- Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
- Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
- Subjects requiring dual anti-platelet therapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780987
Locations
| Japan | |
| Aichi Medical University Hospital | |
| Nagakute, Aichi, Japan, 480-1195 | |
| Toho University Sakura Medical Center | |
| Sakura, Chiba, Japan, 285-8741 | |
| Kokura Memorial Hospital | |
| Kitakyusyu, Fukuoka, Japan, 802-8555 | |
| Hiroshima General Hospital | |
| Hatsukaichi, Hiroshima, Japan, 738-8503 | |
| Teine Keijinkai Hospital | |
| Sapporo, Hokkaido, Japan, 006-8555 | |
| Kanazawa Medical University Hospital | |
| Kahoku-gun, Ishikawa, Japan, 920-0293 | |
| Yokohama Minami Kyousai Hospital | |
| Yokohama, Kanagawa, Japan, 236-0037 | |
| National Hospital Organization Yokohama Medical Center | |
| Yokohama, Kanagawa, Japan, 245-8575 | |
| Mie University Hospital | |
| Tsu, MIE, Japan, 514-8507 | |
| National Hospital Organization Okayama Medical Center | |
| Okayama City, Okayama, Japan, 701-1192 | |
| Kinki University Hospital | |
| Osakasayama, Osaka, Japan, 589-8511 | |
| National Cerebral and Cardiovascular Center Hospital | |
| Suita-shi, Osaka, Japan, 565-8565 | |
| St. Luke's International Hospital | |
| Chuo-ku, Tokyo, Japan, 104-8560 | |
| Nihon University Itabashi Hospital | |
| Itabashi-ku, Tokyo, Japan, 173-8610 | |
| National Hospital Organization Tokyo Medical Center | |
| Meguro-ku, Tokyo, Japan, 152-8902 | |
| Japanese Red Cross Musashino Hospital | |
| Musashino, Tokyo, Japan, 180-8610 | |
| Tokyo Medical University Hospital | |
| Shinjuku-ku, Tokyo, Japan, 160-0023 | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan, 960-1295 | |
| Kumamoto University Hospital | |
| Kumamoto, Japan, 860-8556 | |
| Saiseikai Kumamoto Hospital | |
| Kumamoto, Japan, 861-4193 | |
Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01780987 History of Changes |
| Other Study ID Numbers: |
B0661024 CV185160 ( Other Identifier: BMS ) |
| First Posted: | January 31, 2013 Key Record Dates |
| Results First Posted: | June 23, 2016 |
| Last Update Posted: | June 23, 2016 |
| Last Verified: | May 2016 |
Keywords provided by Pfizer:
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DVT PE VTE |
Additional relevant MeSH terms:
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Thrombosis Embolism Pulmonary Embolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Apixaban Calcium heparin |
Heparin Warfarin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |